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Comparison of Delivery Routes of Flu Vaccine in Adults

NCT00170547 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1597

Last updated 2014-12-05

No results posted yet for this study

Summary

This protocol is to compare the immune response of different influenza vaccines given by two different routes of administration in healthy adults ages 18 to 64 years.

Conditions

Interventions

BIOLOGICAL

Trivalent inactivated influenza vaccine

A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain.. Group 4: 382 subjects receive Fluzone 15 mcg IM on day 0

BIOLOGICAL

Trivalent inactivated influenza vaccine

A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain. Group 1: 382 subjects receive 6 mcg ID with BD system. Group 2: 382 subjects receive 9 mcg ID with BD system, all doses on day 0.

BIOLOGICAL

Trivalent inactivated influenza vaccine

A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain..Group 3: 382 subjects receive 3 mcg Fluzone ID using Mantoux technique on day 0.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2006-01-31
Completion
2006-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00170547 on ClinicalTrials.gov